PAIN RELEASE- menthol kit

Pain Release by

Drug Labeling and Warnings

Pain Release by is a Otc medication manufactured, distributed, or labeled by Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

GET READY FOR WELLNESS

Experience relief from muscular and joint aches from backache, arthritis, sprains and strains with this pain-relieving convenience kit.  Includes our popular roll-on oil blend, mist, massage oil, and bath salts.  Everything you need to feel better naturally. No pain, all gain. 

Kit Contains 4 Saje Favorites:

PAIN RELEASE topical analgesic oil blend

PAIN RELEASE topical analgesic massage oil

PAIN RELEASE topical analgesic mist

PAIN RELEASE topical analgesic bath salt soak

IMPORTANT: FOR EACH PRODUCT, READ ALL PRODUCT INFORMATION ON OUTER AND INNER BOX FLAP BEFORE USING.  KEEP THIS PACKAGE FOR FULL INFORMATION.

DO NOT USE IF ANY OF THE FOLLOWING SECURITY FEATURES ARE BROKEN OR MISSING:
SEAL AROUND BOTTLE (OIL BLEND & MASSAGE OIL) | SEAL AROUND BOTTLE'S CAP AND NECK (MIST) | TEAR NOTCH ON ZIPPERED BAG INSIDE (SALTS)

Distributed by: SAJE NATURAL WELLNESS | 500 - 88 East Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada

We support recycling. Please recycle where possible

SKU 22250701

Lift here to continue to read important product information on all products.

PAIN RELEASE topical analgesic oil blend  Drug Facts  Active ingredient 

Menthol 1.98%

PURPOSE

Purpose Topical Analgesic

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not use

• on wounds or damaged skin
• if epileptic
• with high blood pressure

When using this product

• avoid contact with the eyes
• do not bandage tightly

Stop use and ask a doctor if 

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breastfeeding,

do not use this product. 

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years of age and older: Apply to affected area

DOSAGE & ADMINISTRATION

     not more than 3 to 4 times daily.

• Not recommended for children under 12 years of age.

Inactive ingredients

Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and vitis vinifera (grape) seed oil. 

PAIN RELEASE topical analgesic oil blend

Apply to muscles and joints experiencing minor aches and pains, as directed: 

A - Shoulders

B - Neck

C - Back

D - Elbows

E - Hands

F - Soles of feet

G - Hips

H - Thighs

I - Knees

J - Calves

PAIN RELEASE topical analgesic massage oil  Drug Facts Active ingredient 

Menthol 1.37%

PURPOSE

Purpose Topical Analgesic

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

For external use only. 

Flammable. Keep away from fire or flame.

Do not use

• on wounds or damaged skin
• if epileptic
• with high blood pressure

When using this product,

• avoid contact with the eyes
• do not bandage tightly

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding, 

do not use this product

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right awa y.  

Directions

• Adults and children 12 years of age and older: Apply to affected area

DOSAGE & ADMINISTRATION

      not more than 3 to 4 times daily

• Children under 12 years of age: Consult a doctor.

Inactive ingredients

Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, prunus armeniaca (apricot) kernel oil, rosmarinus officinalis (rosemary) leaf oil, tocopherol, and vitis vinifera (grape) seed oil.

PAIN RELEASE topical analgesic mist  Drug Facts Active ingredient 

Menthol 0.25%

PURPOSE

Purpose Topical Analgesic

Uses For the temporary relief of pain and itching associated with minor cuts, scrapes, or insect bites

Warnings

For external use only.

Do not use 

• if epileptic
• with high blood pressure

When using this product,

avoid contact with the eyes.

Stop use and ask a doctor if 

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. 

If pregnant or breastfeeding,

do not use this product

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years of age and older: Apply to affected area

DOSAGE & ADMINISTRATION

     not more than 3 to 4 times daily

• Children under 12 years of age: Consult a doctor. 

Inactive ingredients

Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and water.

PAIN RELEASE pain relieving bath salt soak  Drug Facts Active ingredient 

Menthol 0.16%

PURPOSE

Purpose External Analgesic

Uses For the temporary relief of pain and itching associated with scrapes, insect bites, and minor skin irritations. 

Warnings

For external use only.

Do not use

• if epileptic
• with high blood pressure

When using this product,

avoid contact with the eyes.

Stop use and ask a doctor if 

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding, 

do not use this product.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years of age and older: Apply to affected area

DOSAGE & ADMINISTRATION

      by dissolving 2 teaspoons of salt soak in warm water and soaking area not more than 3 to 4 times daily.

• Children under 12 years of age: Consult a doctor.

Inactive ingredients

Anthemis nobilis flower oil, cinnamomum camphora (camphor) bark oil, corn starch, epsom salt, eucalyptus oil, lavender oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, sea salt, and sodium bicarbonate.

PRINCIPAL DISPLAY PANEL

Saje Natural Wellness

PAIN RELEASE KIT

topical analgesic convenience kit

1 TOPICAL ANALGESIC OIL BLEND 0.34 FL.OZ. | 10 mL

1 TOPICAL ANALGESIC MASSAGE OIL 1.4 FL.OZ. | 40 mL

1 TOPICAL ANALGESIC MIST 1 FL.OZ. | 30 mL

1 TOPICAL ANALGESIC BATH SALT SOAK NET WT. 4.2 OZ. | 120 g

INGREDIENTS AND APPEARANCE

PAIN RELEASE 
menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69204-006

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69204-006-12	1 in 1 KIT	10/16/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DROPPER	10 mL
Part 2	1 BOTTLE, DROPPER	40 mL
Part 3	1 BOTTLE, SPRAY	30 mL
Part 4	1 POUCH	120 g

Part 1 of 4

PAIN RELEASE 
menthol oil

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	17.62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CAJUPUT OIL (UNII: J3TO6BUQ37)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY OIL (UNII: 8LGU7VM393)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Product Characteristics
Color	white (clear)	Score
Shape	FREEFORM (oil)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Part 2 of 4

PAIN RELEASE 
menthol oil

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.19 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CAJUPUT OIL (UNII: J3TO6BUQ37)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
PEPPERMINT OIL (UNII: AV092KU4JH)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ROSEMARY OIL (UNII: 8LGU7VM393)
TOCOPHEROL (UNII: R0ZB2556P8)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Product Characteristics
Color	white (clear)	Score
Shape	FREEFORM (oil)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		40 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Part 3 of 4

PAIN RELEASE 
menthol liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.23 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CAJUPUT OIL (UNII: J3TO6BUQ37)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY OIL (UNII: 8LGU7VM393)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (clear)	Score
Shape	FREEFORM (liquid)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Part 4 of 4

PAIN RELEASE 
menthol granule

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
CAMPHOR OIL (UNII: 75IZZ8Y727)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SWEET MARJORAM OIL (UNII: ICH7BE016E)
PEPPERMINT OIL (UNII: AV092KU4JH)
ROSEMARY OIL (UNII: 8LGU7VM393)
SEA SALT (UNII: 87GE52P74G)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 PACKAGE
1		120 g in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/16/2016

Labeler - Natures Formulae Health Products Ltd. (241385587)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(69204-006)